Post Approval Monitoring
The Post Approval Monitoring and Education program has three goals:
- Enhance protection of research subjects
- Enhance quality of research data
- Enhancement of the education program
Post-approval monitoring is done by staff within the office of the Vice President for Research (VPR) in accordance with their Standard Operating Procedures.
The VPR Post Approval Monitor(s) will attend IRB meetings to provide feedback to the IRB members.
The reason(s) for on-site review may include:
- random selections,
- complex projects involving unusual levels or types of risks to subjects,
- projects conducted by an investigator who previously failed to comply with IRB determinations, or
- projects where continuing review or reports from other sources have indicated that changes without IRB approval may have occurred or subjects were consented inappropriately,
- HIPAA non-compliance,
- subject or whistleblower complaints, or
- a request by an IRB member and with approval by the IRB.
There may be times when a research study is viewed as sensitive or particularly risky or when for other reasons, the board has concerns regarding the process for obtaining informed consent. In these cases, the IRB-HSR may request Consent observation. Consent observation may be requested for one or more subjects.
Consent observation is performed by the Post-Approval Monitoring personnel. The IRB-HSR will inform the study team that consent observation is required. It is the responsibility of the study team to coordinate consent observation with the Post Approval Monitoring personnel. The Post Approval Monitoring personnel provide documentation of consent observations.
Post Approval Monitoring Process
The conduct of an on-site review may include but is not limited to:
- requests for progress reports from investigators,
- examinations of research records, including signed informed consent documents, protocol modifications, and unexpected, serious, and/or related adverse experience reports,
- contacts with research subjects, or
- observation of the consent process and/or research procedures. Examples of when observation of the consent process could occur are:
o Full board IRB determines during review of a project that a conflict of interest exists such that the informed consent process should be observed by a neutral party;
o IRB is made aware of a complaint or concern with regard to the informed consent process; or
o IRB determines as a result of the monitoring process that the consent process is insufficient and education/training is required for conduct of consent.
Post Approval Monitoring Working Group
The Research Compliance Monitors submit reports to a Post Approval Monitoring (PAM) Working Group consisting of the Associate VP for Research, Research Compliance Coordinators, IRB Directors, IRB Educators, and professional staff of the School of Medicine Clinical Trials office. The PAM Working Group will review the reports and make recommendations to the IRB PAM Advisory Committee.
IRB Post Approval Monitoring Advisory Committee
The IRB-HSR PAM Advisory Committee will include no more than 6 members and will be chaired by the IRB-HSR chair. Members of the IRB-HSR will be invited to serve on the PAM Advisory Committee by the IRB-HSR chair. The members will serve on the committee for a two year term. Additional terms may be allowed at the discretion of the IRB-HSR Chair. Members will include at least one of each of the following individuals from the membership of the IRB-HSR:
- Un-affiliated member
The following individuals may also attend the meeting as non-voting members:
- IRB-HSR Vice Chair
- IRB-HSR Director
- IRB-HSR Associate Director
- SOM CTO Director or designee
- SOM CTO Educator
- IRB Education Coordinator(s)
- Associate VP for Research
- PAM Compliance Monitors
- Others by invitation of IRB Chair
The meeting may be held in person or by conference call.
The post-approval compliance monitors from the Office of the Vice President for Research will conduct post-approval monitoring reviews. The procedures for doing post-approval monitoring are outlined in VPR PAM SOPS #1-1 to #1-8.
Aggregate results of the post-approval monitoring visits will be reported every 6 months by the post-approval monitors to the IRB-HSR members.
On a monthly basis the post approval monitors will send a detailed report of the audits conducted during the previous month to the members of the IRB-HSR Post Approval Monitoring (PAM) Advisory Committee.
The IRB-HSR PAM Advisory Committee acts as an advisory board to the IRB Chair as he/she makes determinations regarding compliance issues. The issues raised may come from PAM audits or other sources. The IRB-HSR PAM Advisory Committee may consult with outside specialists as deemed necessary.
- Make recommendations to implement corrective actions
- Request the post approval monitors review all active protocols of Principal Investigator
- Request subsequent post-approval monitoring visits
- Require investigators to attend educational seminar
- Require protocol to be re-audited at specific time/ enrollment period
- Require PI to notify subjects of non-compliance and get their permission to use the data
- Notify department chair, dean, and/or research ethics committee
- Notify all investigators at institution via education programs to ensure all are aware of regulations, so the noncompliance would be less likely to happen again.
- Determination regarding use of data.
- Require PI to be mentored for a specific period of time
- If there are concerns regarding scientific misconduct such as fraud or IRS issues, notify the UVA Research Integrity Officer at 434-924-3606
In addition to the actions by the chair, the full IRB-HSR may also:
- Suspension of subject enrollment
- Suspension (protocol closed to treatment)
- Termination of IRB-HSR approval ( protocol closed)
- Replacement of PI
- Disallow PI to conduct research for a period of time
- Require PI to inform journals of noncompliance when submitting for publication
- If noncompliance put subjects at risk, may request a consultation with a specialist in the field.
- Consult with OHRP regarding appropriate corrective action
If there are concerns regarding scientific misconduct such as fraud or IRS issues, notify the UVA Research Integrity Officer at 434-924-3606.
Non-Compliance: Auditing for Cause
Information regarding non-compliance in human subjects studies may come to the attention of the IRB in several ways.
- information contained in new applications,
- continuing reviews,
- adverse event reports, and
- reports from collaborators, employees, the public, or subjects.
The chair of the appropriate IRB reviews allegations of non-compliance.
The chair makes a determination as to whether the alleged practices appear to
- cause injury or any other unanticipated problems involving risks to subjects or others, or
- constitute serious or continuing non-compliance with IRB determinations or federal regulations.
In such cases, the chair may suspend the study procedures pending a timely investigation and review by the full IRB.
At the discretion of the chair or board, a study may continue while minor incidents of noncompliance are under investigation. The chair may elect to discuss an allegation of noncompliance with the IRB prior to suspending the protocol if it is apparent that there is no increased risk to subjects.
The Chair and/or the AVPR, may suspend studies when:
- the violation is a clear violation of the regulations,
- a violation of university policy, or
- there is imminent danger to subjects.
The chair and/or the IRB will confirm this action as soon as possible.
Allegations of Misconduct
Investigations by the IRB focus on the protection of study subjects. In cases that involve allegations of research misconduct, the chair contacts the University of Virginia Research Integrity Officer (RIO) for further action. This does not preclude the chair or any member of the IRB from independently contacting the RIO about any allegation of research misconduct. Inquiries or investigations into research misconduct do not preclude IRB review and actions.